Mechanism of Action

PROVENGE Activates the Immune System to Fight Advanced Prostate Cancer

PROVENGE is the first and only FDA-approved personalized immunotherapy.

The active component of PROVENGE is made by culturing a patient’s own immune cells with a prostate-specific antigen. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer cells.

Watch the video: Learn more about the PROVENGE mechanism of action.

To view the mechanism of action diagram in more detail, click here.

Next: Phase 3 IMPACT Trial

INDICATION

PROVENGE^® (sipuleucel-T) is approved by the FDA as an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Please see the Full Prescribing Information.

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